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Polydextrose for Patients With Chronic Kidney Disease

Sponsor
Universidade Federal Fluminense (Other)
Overall Status
Completed
CT.gov ID
NCT05336305
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
7
Actual Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Constipation is a common complication in patients with chronic kidney disease (CKD), especially in hemodialysis (HD) patients. Reduced intake of fibre-rich food is among the most important causes of constipation. The study aims to investigate the possible influence of polydextrose (PDX) supplementation on constipation in patients with CKD on HD.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Polydextrose
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effects of Polydextrose Supplementation on Constipation in Patients Undergoing Hemodialysis
Actual Study Start Date :
Mar 30, 2021
Actual Primary Completion Date :
May 30, 2021
Actual Study Completion Date :
Oct 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo Group

Administration of corn starch daily for 2 months

Dietary Supplement: Polydextrose
Administration of 3g polydextrose per day, for 2 months
Experimental: polydextrose

Administration of 12g polydextrose daily for 2 months

Dietary Supplement: Polydextrose
Administration of 3g polydextrose per day, for 2 months

Outcome Measures

Primary Outcome Measures

  1. Change constipation status after supplementation with polydextrose [2 months]

    Stool frequency and Bristol Stool Form

  2. Change in cytokines plasma levels measured by ELISA after supplementation with polydextrose [2 months]

    cytokines levels

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Clinical diagnosis of Chronic Kidney Disease

  • Hemodialysis patients for more than 6 months

  • Aged 18 years or older

Exclusion Criteria:

  • Patients pregnant

  • Smokers

  • Using antibiotics in the last 3 months

  • Autoimmune diseases

  • Clinical diagnosis of infectious diseases

  • Clinical diagnosis of Cancer

  • Clinical diagnosis of AIDS

Contacts and Locations

Locations

Site City State Country Postal Code
1 Denise Mafra Rio de Janeiro RJ Brazil 22260050

Sponsors and Collaborators

  • Universidade Federal Fluminense

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Denise Mafra, professor, Universidade Federal Fluminense
ClinicalTrials.gov Identifier:
NCT05336305
Other Study ID Numbers:
  • DeniseMafra15
First Posted:
Apr 20, 2022
Last Update Posted:
Apr 20, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Constipation

Study Results

No Results Posted as of Apr 20, 2022